Psoriasis: brodalumab demonstrates long-term safety, efficacy in phase 3

  • Puig L & al.
  • J Am Acad Dermatol
  • 5 Jun 2019

  • International Clinical Digest
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Takeaway

  • Brodalumab (Siliq) is associated with sustained efficacy and safety for patients with moderate to severe plaque psoriasis in 120-week results from the phase 3 AMAGINE-2 trial.

Why this matters

  • Sustained skin clearance is an unmet need in patients with psoriasis; this study suggests that brodalumab represents a good long-term treatment option.

Key results

  • At 120 weeks, brodalumab 210 mg every 2 weeks was associated with 84.4% of patients achieving ≥75% reduction in Psoriasis Area and Severity Index (PASI-75), 75.6% of patients achieving PASI-90, and 61.1% of patients achieving PASI-100 (observed data).
  • At 120 weeks, PASI 75, PASI 90, and PASI 100 response rates based on nonresponder imputation analysis were 39.2%, 35.1%, and 28.4% less, respectively, than response rates based on observed data analysis.
  • The overall exposure-adjusted event rate of treatment-emergent adverse events (TEAEs) for patients treated with brodalumab was 306.9 per 100 patient-years.
    • The most common TEAEs were arthralgia, headache, diarrhea, oropharyngeal pain, and Candida infections.

Study design

  • 1790 patients with psoriasis who received brodalumab were included.
  • Funding: Amgen; Ortho Dermatologics.

Limitations

  • A large number of discontinuations near the end of the study led to differences between observed data and nonresponder imputation results.